Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)
2012年3月15日 更新者：GlaxoSmithKline
The specific aim of this study is to describe 1 year Advair dispensing rates for patients with COPD, and to measure the association between Advair adherence and healthcare utilization (e.g.
emergency room visits and inpatient admissions, etc.).
To compare the risk of a COPD exacerbation (moderate or severe) during a 3-month follow-up period between patients thqat are adherent versus those that are not.
研究概览
研究类型
观察性的
注册 (实际的)
11060
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients 40 years of age or older with at least one pharmacy claim for FSC during the index date range (July 1, 2005 through June 30, 2006).
An index date was designated as the date of the first pharmacy claim for FSC.
Patients were also required to have continuous medical and pharmacy eligibility for the 12 month pre-Index year and the 12 month Index year (referred to as the 24 month observation period), and the 3 month post-Index outcome period (referred to as the outcome period).
Eligible patients were further required to have at least one medical claim with a diagnosis (either primary or secondary) of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, and 496), AND at least 1 pharmacy claim for an anticholinergic medication, both occurring during the12 month pre-index period.
描述
INCLUSION CRITERIA
- at least one pharmacy claim for Advair (any strength; Diskus or MDI) during the index year (July 1, 2005 through June 30, 2006).
- Continuous medical and pharmacy eligibility for the 12 month Pre-Index year and the 12 month Index year (referred to as the 24 month Observation Period), and the 3 month Post-Index period (referred to as the Outcome Period).
- At least one medical claim with a diagnosis (either primary or secondary) of COPD (ICD-9 code 490.xx, 491.xx, 492.xx, and 496), AND at least 1 pharmacy claim for an Anticholinergic medication, both occurring during the12 month pre-index period.
- At least 40 years old at index date.
EXCLUSION CRITERIA
- any medical claim (ever) with a primary or secondary diagnosis of cystic fibrosis (ICD-9 code 277.0x).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：追溯
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
COPD
Patients with a diagnosis code of COPD
|
fluticasone propionate/salmeterol xinafoate combination
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Number of Pharmacy Claims by Participants During the Post-Index Period
大体时间：One Year
|
The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured.
|
One Year
|
|
Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period
大体时间：One Year
|
The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured.
|
One Year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年8月1日
初级完成 (实际的)
2010年5月1日
研究完成 (实际的)
2010年5月1日
研究注册日期
首次提交
2011年6月23日
首先提交符合 QC 标准的
2011年6月24日
首次发布 (估计)
2011年6月27日
研究记录更新
最后更新发布 (估计)
2012年3月29日
上次提交的符合 QC 标准的更新
2012年3月15日
最后验证
2012年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.